Pharma Firms Comply with New Antibiotics Rules

Most drug manufacturers agree to follow the Food and Drug Administration’s new labeling guidelines for antibiotics used in farm animals.

Mar 31, 2014

Rina Shaikh-Lesko

WIKIMEDIA, RYAN THOMPSON/US DEPARTMENT OF AGRICULTURENearly every pharmaceutical company that produces antibiotics meant to increase growth in livestock will abide by new voluntary guidelines and change the labeling on their drugs to reflect new US Food and Drug Administration (FDA) rules, the agency announced last week (March 27). The new rules, introduced by the FDA last year, prohibit the use of antibiotics in feed solely to enhance animal size. If an animal requires antibiotics because of illness, farmers need to obtain a veterinarian’s prescription.

Implementing those rules, however, requires the cooperation of 26 pharmaceutical firms. The 25 that have agreed to the new guidelines to date were responsible for more than 99.9 percent of the 2011 sales of the antibiotics affected by the new regulations, FDA said. The only company that did not agree to the new guidance is the Norwegian company Pharmaq AS, which produces an antimicrobial powder for salmon, trout, and catfish.

“The FDA and drug makers appear to have passed the first big test of the agency’s voluntary approach,” Laura Rogers, the director of human health and industrial farming for The Pew Charitable Trusts told Reuters. Rogers also cautioned that more tests would follow.

Critics worry that the voluntary nature of the guidelines provides no way to enforce the new rules. “This plan is likely to lead to label changes, not a reduction in use,” Avinash Kar, a health attorney with the Natural Resources Defense Council, told Reuters.